RSV Illness in ≤12 Months of Participants
Conditions
Keywords
Respiratory Syncytial Virus illness, RSV
Brief summary
The primary objective of this study is to describe the effect of a single dose of medication compared to placebo in the upper respiratory tract in previously healthy children less than or equal to 12 months of age who are hospitalized with lower respiratory tract illness.
Detailed description
The primary objective of this study is to describe the effect of a single 30 mg/kg or 100 mg/kg intravenous (IV) dose of Motavizumab compared to placebo on study drug levels and viral load as measured by cultivatable virus and real-time reverse transcriptase-polymerase chain reaction (RT-PCR) in the upper respiratory tract in previously healthy children ≤12 months of age who are hospitalized with lower respiratory tract illness.
Interventions
BIOLOGICALMotavizumab
A single IV dose of motavizumab 30 mg/kg or 100 mg/kg will be administered on Day 0 of the study.
OTHERPlacebo
A single IV dose of placebo matched to motavizumab will be administered on Day 0 of the study.
Sponsors
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
Children must meet all of the following criteria: * Previously healthy * Age less or equal to 12 months at the time of randomization * Gestational age more or equal to 36 weeks * Hospitalized for lower respiratory tract illness (i.e., RSV bronchiolitis and/or pneumonia) * Documented positive RSV test within 48 hours prior to randomization * Randomization within 12 hours of the decision to hospitalize a child for RSV illness * Written informed consent obtained from the participant's parent(s)/legal guardian
Exclusion criteria
Children must have none of the following: * Prior receipt of or receiving ribavirin or other anti-viral treatment for the current episode of RSV infection prior to randomization * Any use of systemic or inhaled steroids within the past 30 days prior to randomization * Intubation for ventilatory support at randomization * Any medically significant underlying ongoing chronic illness or organ system dysfunction, or other known acute illness except for RSV infection * Known renal impairment, hepatic dysfunction, hematologic abnormalities, seizure or other neurologic disorder or immunodeficiency * Requirement for supplemental oxygen at any time prior to the current RSV infection (brief use of oxygen in the immediate postnatal period to treat a transient condition is allowed) * Mechanical ventilation at any time prior to the onset of the current RSV infection * Congenital heart disease \[children with medically or surgically closed patent ductus arteriosis (PDA), small atrial septal defect (ASD) or small ventricular septal defect (VSD) will be allowed\] * Previous reaction to IVIG, blood products, or other foreign proteins * Prior use of intravenous immunoglobulin (IVIG), palivizumab (SynagisÒ), or other immunoglobulin products within the past 2 months * Currently receiving other investigational agents or have received any other investigational agents within the 3 months prior to randomization * Prior or current participation in any investigational study with a therapeutic agent or vaccine for RSV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 | Day 0 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\<=12) months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | Day 1 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | Day 2 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | Day 3 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | Day 4 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | Day 5 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | Day 6 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | Day 7 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | Day 30 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | Day 90 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 | Day 180 | The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness. |
| Motavizumab Concentration in Nasal Wash Aspirates at Day 0 | Day 0 | Motavizumab concentration in nasal wash aspirates is reported. |
| Motavizumab Concentration in Nasal Wash Aspirates at Day 1 | Day 1 | Motavizumab concentration in nasal wash aspirates is reported. |
| Motavizumab Concentration in Nasal Wash Aspirates at Day 2 | Day 2 | Motavizumab concentration in nasal wash aspirates is reported. |
| Motavizumab Concentration in Nasal Wash Aspirates at Day 7 | Day 7 | Motavizumab concentration in nasal wash aspirates is reported. |
| Motavizumab Concentration in Nasal Wash Aspirates at Day 30 | Day 30 | Motavizumab concentration in nasal wash aspirates is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From the start of study drug (Day 0) through Day 90 | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Duration of RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Duration of RSV hospitalization is reported. |
| Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | From the start of study drug (Day 0) through Day 30 | — |
| Respiratory Assessment Change Score (RACS) Derived From Baseline | Baseline (Day 0), Days 1, 2, 3, 7, and 30 | The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration. |
| Oxygen Saturation Level During RSV Hospitalization | Days 0, 1, 2, 3, 7, and 30 | Oxygen saturation level during RSV hospitalization is reported. |
| Heart Rate During RSV Hospitalization | Days 0, 1, 2, 3, 7, and 30 | Heart rate during RSV hospitalization is reported. |
| Respiratory Rate During RSV Hospitalization | Days 0, 1, 2, 3, 7, and 30 | Respiratory rate during RSV hospitalization is reported. |
| Number of Participants With Supplemental Oxygen Use During RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Number of participants with supplemental oxygen use during RSV hospitalization is reported. |
| Duration of Supplemental Oxygen Use During RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Duration of supplemental oxygen use during RSV hospitalization is reported. |
| Number of Participants on Mechanical Ventilation During RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Number of participants on mechanical ventilation during RSV hospitalization is reported. |
| Duration of Mechanical Ventilation During RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Duration of mechanical ventilation during RSV hospitalization is reported. |
| Number of Participants Admitted to the Intensive Care Unit (ICU) | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Number of participants admitted to ICU is reported. |
| Duration of ICU Stay During RSV Hospitalization | From Randomization Day (Day 0) to Discharge Day (up to Day 30) | Duration of ICU stay during RSV hospitalization is reported. |
| Number of Participants With Medically-attended Wheezing Episodes | From randomization (Day 0) through Day 360 (approximately 12 months) | Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events. |
| Serum Concentration of Motavizumab | Days 1, 7, 90, 180, and 360 | Motavizumab concentration in serum is reported. |
| Number of Participants With Detectable Anti-motavizumab Antibodies | Days 0, 180, and 360 | Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater. |
| Change From Baseline in Serum Cytokine Levels | Baseline (Day 0, pre-dose) through Day 360 | — |
| Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Baseline (Day 0, pre-dose) through Day 180 | Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported. |
Countries
Australia, Chile, New Zealand, Panama, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received a single intravenous (IV) dose of placebo matched to motavizumab on Day 0 of the study. | 40 |
| Motavizumab 30 mg/kg Participants received a single IV dose of motavizumab 30 mg/kg on Day 0 of the study. | 39 |
| Motavizumab 100 mg/kg Participants received a single IV dose of motavizumab 100 mg/kg on Day 0 of the study. | 39 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Did not attend Day 360 visit | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 | 5 |
| Overall Study | Mistakenly randomized, chose not to participate in study | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | Placebo | Motavizumab 30 mg/kg | Motavizumab 100 mg/kg | Total |
|---|---|---|---|---|
| Age, Continuous | 3.72 Months STANDARD_DEVIATION 2.9 | 3.07 Months STANDARD_DEVIATION 2.62 | 3.47 Months STANDARD_DEVIATION 2.98 | 3.42 Months STANDARD_DEVIATION 2.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 35 Participants | 32 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 4 Participants | 7 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 9 Participants | 24 Participants |
| Race (NIH/OMB) White | 26 Participants | 26 Participants | 27 Participants | 79 Participants |
| Sex: Female, Male Female | 11 Participants | 19 Participants | 19 Participants | 49 Participants |
| Sex: Female, Male Male | 29 Participants | 20 Participants | 20 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 30 / 37 | 22 / 38 | 24 / 38 |
| serious Total, serious adverse events | 6 / 37 | 6 / 38 | 7 / 38 |
Outcome results
Primary
Motavizumab Concentration in Nasal Wash Aspirates at Day 0
Motavizumab concentration in nasal wash aspirates is reported.
Time frame: Day 0
Population: Evaluable population for pharmacokinetics (PK) included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 0 were analyzed for the outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Motavizumab Concentration in Nasal Wash Aspirates at Day 0 | 0.93 ng/mL | Standard Deviation 5.72 |
| Motavizumab 30 mg/kg | Motavizumab Concentration in Nasal Wash Aspirates at Day 0 | 0.00 ng/mL | Standard Deviation 0 |
p-value: 1Wilcoxon's rank-sum test
Primary
Motavizumab Concentration in Nasal Wash Aspirates at Day 1
Motavizumab concentration in nasal wash aspirates is reported.
Time frame: Day 1
Population: Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 1 were analyzed for the outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Motavizumab Concentration in Nasal Wash Aspirates at Day 1 | 4673.3 ng/mL | Standard Deviation 5397.4 |
| Motavizumab 30 mg/kg | Motavizumab Concentration in Nasal Wash Aspirates at Day 1 | 10087 ng/mL | Standard Deviation 10242 |
p-value: 0.05Wilcoxon's rank-sum test
Primary
Motavizumab Concentration in Nasal Wash Aspirates at Day 2
Motavizumab concentration in nasal wash aspirates is reported.
Time frame: Day 2
Population: Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 2 were analyzed for the outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Motavizumab Concentration in Nasal Wash Aspirates at Day 2 | 2341.2 ng/mL | Standard Deviation 2928.4 |
| Motavizumab 30 mg/kg | Motavizumab Concentration in Nasal Wash Aspirates at Day 2 | 7436.7 ng/mL | Standard Deviation 10321 |
p-value: 0.008Wilcoxon's rank-sum test
Primary
Motavizumab Concentration in Nasal Wash Aspirates at Day 30
Motavizumab concentration in nasal wash aspirates is reported.
Time frame: Day 30
Population: Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 30 were analyzed for the outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Motavizumab Concentration in Nasal Wash Aspirates at Day 30 | 431.21 ng/mL | Standard Deviation 597.6 |
| Motavizumab 30 mg/kg | Motavizumab Concentration in Nasal Wash Aspirates at Day 30 | 1934.5 ng/mL | Standard Deviation 3055.6 |
p-value: <0.001Wilcoxon's rank-sum test
Primary
Motavizumab Concentration in Nasal Wash Aspirates at Day 7
Motavizumab concentration in nasal wash aspirates is reported.
Time frame: Day 7
Population: Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in nasal wash aspirates at Day 7 were analyzed for the outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Motavizumab Concentration in Nasal Wash Aspirates at Day 7 | 966.37 ng/mL | Standard Deviation 1016 |
| Motavizumab 30 mg/kg | Motavizumab Concentration in Nasal Wash Aspirates at Day 7 | 2464.2 ng/mL | Standard Deviation 2788 |
p-value: 0.012Wilcoxon's rank-sum test
Primary
Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children less than or equal to (\<=12) months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 0
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 0 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 | 8.13 log10 copies/mL | Standard Deviation 0.73 |
| Motavizumab 30 mg/kg | Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 | 8.05 log10 copies/mL | Standard Deviation 1.22 |
| Motavizumab 100 mg/kg | Respiratory Syncytial Virus (RSV) Load in the Upper Respiratory Tract as Measured by Quantitative Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) at Day 0 | 8.15 log10 copies/mL | Standard Deviation 0.86 |
p-value: 0.218Wilcoxon's rank-sum test
p-value: 0.643Wilcoxon's rank-sum test
p-value: 0.677Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 1
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 1 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | 7.61 log10 copies/mL | Standard Deviation 0.86 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | 7.54 log10 copies/mL | Standard Deviation 1.26 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 1 | 7.40 log10 copies/mL | Standard Deviation 1.26 |
p-value: 0.257Wilcoxon's rank-sum test
p-value: 0.726Wilcoxon's rank-sum test
p-value: 0.551Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 180
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 180 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 | 2.68 log10 copies/mL | Standard Deviation 0.95 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 | 2.52 log10 copies/mL | Standard Deviation 0.09 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 180 | 2.50 log10 copies/mL | Standard Deviation 0 |
p-value: 0.742Wilcoxon's rank-sum test
p-value: 0.486Wilcoxon's rank-sum test
p-value: 0.49Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 2
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 2 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | 6.95 log10 copies/mL | Standard Deviation 1.21 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | 6.68 log10 copies/mL | Standard Deviation 1.21 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 2 | 6.59 log10 copies/mL | Standard Deviation 1.35 |
p-value: 0.591Wilcoxon's rank-sum test
p-value: 0.393Wilcoxon's rank-sum test
p-value: 0.586Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 3
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 3 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | 6.12 log10 copies/mL | Standard Deviation 1.15 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | 6.11 log10 copies/mL | Standard Deviation 1.26 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 3 | 5.95 log10 copies/mL | Standard Deviation 1.46 |
p-value: 0.894Wilcoxon's rank-sum test
p-value: 0.674Wilcoxon's rank-sum test
p-value: 0.636Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 30
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 30 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | 3.03 log10 copies/mL | Standard Deviation 1.11 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | 3.05 log10 copies/mL | Standard Deviation 1.33 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 30 | 2.96 log10 copies/mL | Standard Deviation 1.08 |
p-value: 0.988Wilcoxon's rank-sum test
p-value: 0.832Wilcoxon's rank-sum test
p-value: 0.748Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 4
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 4 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | 6.00 log10 copies/mL | Standard Deviation 0.58 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | 5.76 log10 copies/mL | Standard Deviation 0.82 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 4 | 5.41 log10 copies/mL | Standard Deviation 1.44 |
p-value: 0.397Wilcoxon's rank-sum test
p-value: 0.238Wilcoxon's rank-sum test
p-value: 0.461Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 5
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 5 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | 5.52 log10 copies/mL | Standard Deviation 0.68 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | 5.26 log10 copies/mL | Standard Deviation 1.2 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 5 | 5.31 log10 copies/mL | Standard Deviation 1.94 |
p-value: 0.322Wilcoxon's rank-sum test
p-value: 0.747Wilcoxon's rank-sum test
p-value: 0.717Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 6
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples, who tested positive for RSV at Day 6 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | 5.63 log10 copies/mL | Standard Deviation 0.91 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | 5.25 log10 copies/mL | Standard Deviation 1.58 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 6 | 5.60 log10 copies/mL | Standard Deviation 2.08 |
p-value: 0.847Wilcoxon's rank-sum test
p-value: 1Wilcoxon's rank-sum test
p-value: 1Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 7
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 7 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | 4.86 log10 copies/mL | Standard Deviation 1.45 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | 4.73 log10 copies/mL | Standard Deviation 1.27 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 7 | 4.52 log10 copies/mL | Standard Deviation 1.7 |
p-value: 0.653Wilcoxon's rank-sum test
p-value: 0.283Wilcoxon's rank-sum test
p-value: 0.411Wilcoxon's rank-sum test
Primary
RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90
The RSV viral load is measured by cultivatable virus and real-time RT-PCR in the upper respiratory tract in previously healthy children \<=12 months of age who are hospitalized with lower respiratory tract illness.
Time frame: Day 90
Population: The ITT population included all participants who were randomized in the study. Participants with adequate baseline samples and who tested positive for RSV at Day 90 were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | 2.66 log10 copies/mL | Standard Deviation 0.7 |
| Motavizumab 30 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | 2.55 log10 copies/mL | Standard Deviation 0.29 |
| Motavizumab 100 mg/kg | RSV Load in the Upper Respiratory Tract as Measured by Quantitative RT-PCR at Day 90 | 2.50 log10 copies/mL | Standard Deviation 0 |
p-value: 0.28Wilcoxon's rank-sum test
p-value: 0.108Wilcoxon's rank-sum test
p-value: 1Wilcoxon's rank-sum test
Secondary
Change From Baseline in Serum Cytokine Levels
Time frame: Baseline (Day 0, pre-dose) through Day 360
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate cytokine levels were analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Serum Cytokine Levels | IFN gamma induced protein 10 (IP-10): Day 360 | -1089.184 Picograms per millilitre (pg/mL) | Standard Deviation 1711.708 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL12 P70: Day 360 | -10.633 Picograms per millilitre (pg/mL) | Standard Deviation 49.32 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-1 receptor antagonist (RA): Day 360 | -266.925 Picograms per millilitre (pg/mL) | Standard Deviation 502.65 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IFN alpha: Day 360 | -23.980 Picograms per millilitre (pg/mL) | Standard Deviation 121.625 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL13: Day 360 | -0.779 Picograms per millilitre (pg/mL) | Standard Deviation 8.086 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-8: Day 360 | -20.059 Picograms per millilitre (pg/mL) | Standard Deviation 19.79 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Interferon (IFN) gamma: Day 360 | -65.424 Picograms per millilitre (pg/mL) | Standard Deviation 258.871 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-15: Day 360 | -4.999 Picograms per millilitre (pg/mL) | Standard Deviation 14.377 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Il-5: Day 360 | 1.045 Picograms per millilitre (pg/mL) | Standard Deviation 4.661 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Granulocyte macrophage -CSF: Day 360 | -54.862 Picograms per millilitre (pg/mL) | Standard Deviation 185.534 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-17: Day 360 | 2.067 Picograms per millilitre (pg/mL) | Standard Deviation 16.207 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Interleukin-1(IL-1) beta: Day 360 | -3.005 Picograms per millilitre (pg/mL) | Standard Deviation 12.043 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Granulocyte-colony stimulating factor (G-CSF):D360 | -98.351 Picograms per millilitre (pg/mL) | Standard Deviation 192.339 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Eotaxin: Day 360 | -8.790 Picograms per millilitre (pg/mL) | Standard Deviation 138.692 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Rantes: Day 360 | 783.389 Picograms per millilitre (pg/mL) | Standard Deviation 2664.67 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Basic fibroblast growth factor: Day (D) 360 | 1.886 Picograms per millilitre (pg/mL) | Standard Deviation 34.663 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-6: Day 360 | -41.180 Picograms per millilitre (pg/mL) | Standard Deviation 72.12 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Vascular endothelial growth factor (VEGF): Day 360 | -17.908 Picograms per millilitre (pg/mL) | Standard Deviation 135.254 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Platelet-derived growth factor (PDGF)-BB: Day 360 | 3461.665 Picograms per millilitre (pg/mL) | Standard Deviation 5874.913 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-7: Day 360 | -1.328 Picograms per millilitre (pg/mL) | Standard Deviation 7.797 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-2: Day 360 | -7.881 Picograms per millilitre (pg/mL) | Standard Deviation 30.34 |
| Placebo | Change From Baseline in Serum Cytokine Levels | MIP-1 beta: Day 360 | -1.950 Picograms per millilitre (pg/mL) | Standard Deviation 105.553 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Monokine induced by gamma(MIG): Day 360 | 1046.002 Picograms per millilitre (pg/mL) | Standard Deviation 2735.42 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Macrophage inflammatory protein (MIP)-1 alpha:D360 | 0.604 Picograms per millilitre (pg/mL) | Standard Deviation 7.309 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-9: Day 360 | 58.378 Picograms per millilitre (pg/mL) | Standard Deviation 308.184 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Tumor necrosis factor (TNF) alpha: Day 360 | -17.112 Picograms per millilitre (pg/mL) | Standard Deviation 62.119 |
| Placebo | Change From Baseline in Serum Cytokine Levels | Monocyte chemoattractant protein-1: Day 360 | -75.818 Picograms per millilitre (pg/mL) | Standard Deviation 96.097 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL-10: Day 360 | -11.407 Picograms per millilitre (pg/mL) | Standard Deviation 21.458 |
| Placebo | Change From Baseline in Serum Cytokine Levels | IL4: Day 360 | -0.717 Picograms per millilitre (pg/mL) | Standard Deviation 5.733 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Rantes: Day 360 | 2946.934 Picograms per millilitre (pg/mL) | Standard Deviation 8074.666 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Interleukin-1(IL-1) beta: Day 360 | 0.48 Picograms per millilitre (pg/mL) | Standard Deviation 2.442 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-1 receptor antagonist (RA): Day 360 | -107.834 Picograms per millilitre (pg/mL) | Standard Deviation 201.74 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-2: Day 360 | 0.446 Picograms per millilitre (pg/mL) | Standard Deviation 7.604 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL4: Day 360 | 2.187 Picograms per millilitre (pg/mL) | Standard Deviation 8.596 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Il-5: Day 360 | 0.763 Picograms per millilitre (pg/mL) | Standard Deviation 1.817 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-6: Day 360 | -24.305 Picograms per millilitre (pg/mL) | Standard Deviation 61.462 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-7: Day 360 | 0.691 Picograms per millilitre (pg/mL) | Standard Deviation 5.094 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-8: Day 360 | -18.323 Picograms per millilitre (pg/mL) | Standard Deviation 25.204 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-9: Day 360 | -45.673 Picograms per millilitre (pg/mL) | Standard Deviation 188.92 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-10: Day 360 | -6.924 Picograms per millilitre (pg/mL) | Standard Deviation 7.927 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL12 P70: Day 360 | 2.660 Picograms per millilitre (pg/mL) | Standard Deviation 18.759 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL13: Day 360 | 1.744 Picograms per millilitre (pg/mL) | Standard Deviation 3.244 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-15: Day 360 | -0.402 Picograms per millilitre (pg/mL) | Standard Deviation 1.473 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-17: Day 360 | 8.056 Picograms per millilitre (pg/mL) | Standard Deviation 24.954 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Eotaxin: Day 360 | 36.955 Picograms per millilitre (pg/mL) | Standard Deviation 118.098 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Basic fibroblast growth factor: Day (D) 360 | -1.342 Picograms per millilitre (pg/mL) | Standard Deviation 6.92 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Granulocyte-colony stimulating factor (G-CSF):D360 | -91.782 Picograms per millilitre (pg/mL) | Standard Deviation 184.339 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Granulocyte macrophage -CSF: Day 360 | -7.439 Picograms per millilitre (pg/mL) | Standard Deviation 26.842 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Interferon (IFN) gamma: Day 360 | 9.164 Picograms per millilitre (pg/mL) | Standard Deviation 91.58 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IFN alpha: Day 360 | 12.281 Picograms per millilitre (pg/mL) | Standard Deviation 67.767 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | IFN gamma induced protein 10 (IP-10): Day 360 | -1028.280 Picograms per millilitre (pg/mL) | Standard Deviation 1105.987 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Monocyte chemoattractant protein-1: Day 360 | -52.910 Picograms per millilitre (pg/mL) | Standard Deviation 84.827 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Macrophage inflammatory protein (MIP)-1 alpha:D360 | 0.689 Picograms per millilitre (pg/mL) | Standard Deviation 2.485 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | MIP-1 beta: Day 360 | 43.061 Picograms per millilitre (pg/mL) | Standard Deviation 121.617 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Platelet-derived growth factor (PDGF)-BB: Day 360 | 4377.256 Picograms per millilitre (pg/mL) | Standard Deviation 6050.996 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Tumor necrosis factor (TNF) alpha: Day 360 | -2.676 Picograms per millilitre (pg/mL) | Standard Deviation 29.385 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Vascular endothelial growth factor (VEGF): Day 360 | -33.293 Picograms per millilitre (pg/mL) | Standard Deviation 125.224 |
| Motavizumab 30 mg/kg | Change From Baseline in Serum Cytokine Levels | Monokine induced by gamma(MIG): Day 360 | 1086.786 Picograms per millilitre (pg/mL) | Standard Deviation 1246.951 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-2: Day 360 | 108.245 Picograms per millilitre (pg/mL) | Standard Deviation 445.422 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IFN alpha: Day 360 | 194.351 Picograms per millilitre (pg/mL) | Standard Deviation 835.999 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-10: Day 360 | 3.786 Picograms per millilitre (pg/mL) | Standard Deviation 75.604 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Interleukin-1(IL-1) beta: Day 360 | 48.943 Picograms per millilitre (pg/mL) | Standard Deviation 236.734 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IFN gamma induced protein 10 (IP-10): Day 360 | -460.829 Picograms per millilitre (pg/mL) | Standard Deviation 2216.789 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-9: Day 360 | -48.034 Picograms per millilitre (pg/mL) | Standard Deviation 204.545 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Tumor necrosis factor (TNF) alpha: Day 360 | 403.443 Picograms per millilitre (pg/mL) | Standard Deviation 1918.152 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Monocyte chemoattractant protein-1: Day 360 | 17.128 Picograms per millilitre (pg/mL) | Standard Deviation 376.408 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-8: Day 360 | -21.440 Picograms per millilitre (pg/mL) | Standard Deviation 20.033 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-1 receptor antagonist (RA): Day 360 | -171.278 Picograms per millilitre (pg/mL) | Standard Deviation 599.988 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Macrophage inflammatory protein (MIP)-1 alpha:D360 | -31.042 Picograms per millilitre (pg/mL) | Standard Deviation 182.639 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-7: Day 360 | 4.305 Picograms per millilitre (pg/mL) | Standard Deviation 36.131 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Monokine induced by gamma(MIG): Day 360 | 2465.946 Picograms per millilitre (pg/mL) | Standard Deviation 7714.076 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | MIP-1 beta: Day 360 | -1.354 Picograms per millilitre (pg/mL) | Standard Deviation 235.052 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-6: Day 360 | 118.469 Picograms per millilitre (pg/mL) | Standard Deviation 524.68 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Vascular endothelial growth factor (VEGF): Day 360 | -39.069 Picograms per millilitre (pg/mL) | Standard Deviation 87.616 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Eotaxin: Day 360 | 202.122 Picograms per millilitre (pg/mL) | Standard Deviation 728.741 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Platelet-derived growth factor (PDGF)-BB: Day 360 | 3631.464 Picograms per millilitre (pg/mL) | Standard Deviation 9603.609 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Basic fibroblast growth factor: Day (D) 360 | 6.593 Picograms per millilitre (pg/mL) | Standard Deviation 34.509 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-17: Day 360 | 1.092 Picograms per millilitre (pg/mL) | Standard Deviation 22.159 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Il-5: Day 360 | 0.774 Picograms per millilitre (pg/mL) | Standard Deviation 8.296 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Granulocyte-colony stimulating factor (G-CSF):D360 | -42.870 Picograms per millilitre (pg/mL) | Standard Deviation 108.678 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL-15: Day 360 | 33.618 Picograms per millilitre (pg/mL) | Standard Deviation 139.355 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL4: Day 360 | 5.394 Picograms per millilitre (pg/mL) | Standard Deviation 30.426 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Granulocyte macrophage -CSF: Day 360 | 964.242 Picograms per millilitre (pg/mL) | Standard Deviation 4386.145 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL13: Day 360 | 9.893 Picograms per millilitre (pg/mL) | Standard Deviation 54.188 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Rantes: Day 360 | 793.431 Picograms per millilitre (pg/mL) | Standard Deviation 2672.889 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | Interferon (IFN) gamma: Day 360 | 464.277 Picograms per millilitre (pg/mL) | Standard Deviation 2027.072 |
| Motavizumab 100 mg/kg | Change From Baseline in Serum Cytokine Levels | IL12 P70: Day 360 | 48.765 Picograms per millilitre (pg/mL) | Standard Deviation 239.216 |
Secondary
Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels
Change from baseline in upper respiratory tract (nasal wash) cytokine levels are reported.
Time frame: Baseline (Day 0, pre-dose) through Day 180
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with adequate nasal wash cytokine levels at specified time points were analysed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Il-10: Day 180 | -55.412 pg/mL | Standard Deviation 65.437 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-4: Day 180 | -1.761 pg/mL | Standard Deviation 3.09 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN gamma: Day180 | -5754.670 pg/mL | Standard Deviation 27853.042 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-12 P70: Day 180 | -52.927 pg/mL | Standard Deviation 60.597 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | PDGF-BB: Day 180 | -95.616 pg/mL | Standard Deviation 197.836 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | GM-CSF: Day 180 | -86.359 pg/mL | Standard Deviation 139.214 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-13: Day 180 | -54.573 pg/mL | Standard Deviation 151.8 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 RA: Day 180 | -91761.764 pg/mL | Standard Deviation 268797.553 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | G-CSF:Day 180 | -3547.084 pg/mL | Standard Deviation 7428.81 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-15: Day 180 | -4.018 pg/mL | Standard Deviation 17.009 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Rantes: Day 180 | -244.749 pg/mL | Standard Deviation 971.092 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Basic FGF: Day 180 | -82.364 pg/mL | Standard Deviation 125.246 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-17: Day 180 | -22.557 pg/mL | Standard Deviation 27.252 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-5: Day 180 | -0.077 pg/mL | Standard Deviation 1.865 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Eotaxin: Day180 | -16.905 pg/mL | Standard Deviation 140.534 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 beta: Day 180 | -2607.852 pg/mL | Standard Deviation 6378.263 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 beta: Day 180 | -924.715 pg/mL | Standard Deviation 913.488 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-6: Day 180 | -1139.081 pg/mL | Standard Deviation 1061.467 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | VEGF: Day 180 | -1167.204 pg/mL | Standard Deviation 1698.618 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 alpha: Day 180 | -81.063 pg/mL | Standard Deviation 106.178 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-7: Day 180 | -6.553 pg/mL | Standard Deviation 26.065 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-2: Day 180 | -0.849 pg/mL | Standard Deviation 14.116 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MCP-1: Day 180 | -510.596 pg/mL | Standard Deviation 821.385 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-8: Day 180 | -26762.935 pg/mL | Standard Deviation 83539.52 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIG: Day 180 | -42371.446 pg/mL | Standard Deviation 124818.988 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IP-10: Day 180 | 2907.151 pg/mL | Standard Deviation 14396.032 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-9: Day 180 | -32.899 pg/mL | Standard Deviation 40.569 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | TNF alpha: Day 180 | -1489.621 pg/mL | Standard Deviation 3190.856 |
| Placebo | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN alpha: Day180 | -59.346 pg/mL | Standard Deviation 413.227 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-12 P70: Day 180 | -54.300 pg/mL | Standard Deviation 55.463 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | G-CSF:Day 180 | -3732.054 pg/mL | Standard Deviation 9873.369 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 beta: Day 180 | -2575.906 pg/mL | Standard Deviation 3423.519 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 RA: Day 180 | -97050.821 pg/mL | Standard Deviation 200487.75 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-2: Day 180 | -1.215 pg/mL | Standard Deviation 10.959 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-4: Day 180 | -1.897 pg/mL | Standard Deviation 2.939 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-5: Day 180 | -0.351 pg/mL | Standard Deviation 7.077 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-6: Day 180 | -930.388 pg/mL | Standard Deviation 1730.515 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-7: Day 180 | -20.954 pg/mL | Standard Deviation 48.39 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-8: Day 180 | -20794.797 pg/mL | Standard Deviation 30409.576 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-9: Day 180 | -48.923 pg/mL | Standard Deviation 57.492 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Il-10: Day 180 | -65.522 pg/mL | Standard Deviation 107.589 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-13: Day 180 | -59.583 pg/mL | Standard Deviation 116.696 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-15: Day 180 | -7.107 pg/mL | Standard Deviation 14.202 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-17: Day 180 | -31.352 pg/mL | Standard Deviation 25.301 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Eotaxin: Day180 | -42.034 pg/mL | Standard Deviation 90.948 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Basic FGF: Day 180 | -149.153 pg/mL | Standard Deviation 267.861 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | GM-CSF: Day 180 | -79.592 pg/mL | Standard Deviation 119.261 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN gamma: Day180 | -3026.337 pg/mL | Standard Deviation 13551.38 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN alpha: Day180 | -95.529 pg/mL | Standard Deviation 442.959 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IP-10: Day 180 | -21562.675 pg/mL | Standard Deviation 94358.228 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MCP-1: Day 180 | -336.373 pg/mL | Standard Deviation 230.303 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 alpha: Day 180 | -79.610 pg/mL | Standard Deviation 100.858 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 beta: Day 180 | -921.287 pg/mL | Standard Deviation 770.658 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | PDGF-BB: Day 180 | -90.821 pg/mL | Standard Deviation 192.864 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Rantes: Day 180 | -789.419 pg/mL | Standard Deviation 3136.828 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | TNF alpha: Day 180 | -1038.889 pg/mL | Standard Deviation 1660.82 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | VEGF: Day 180 | -1118.459 pg/mL | Standard Deviation 1365.524 |
| Motavizumab 30 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIG: Day 180 | -6693.146 pg/mL | Standard Deviation 25633.807 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-9: Day 180 | -45.623 pg/mL | Standard Deviation 85.438 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Rantes: Day 180 | -194.783 pg/mL | Standard Deviation 493.671 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN alpha: Day180 | -15.090 pg/mL | Standard Deviation 240.549 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-8: Day 180 | -8610.260 pg/mL | Standard Deviation 14715.271 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-2: Day 180 | -0.458 pg/mL | Standard Deviation 9.316 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IP-10: Day 180 | -15729.066 pg/mL | Standard Deviation 93210.658 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-7: Day 180 | -18.219 pg/mL | Standard Deviation 58.02 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 beta: Day 180 | -1772.376 pg/mL | Standard Deviation 3150.626 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MCP-1: Day 180 | -317.251 pg/mL | Standard Deviation 532.157 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-6: Day 180 | -551.482 pg/mL | Standard Deviation 676.661 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | TNF alpha: Day 180 | -610.185 pg/mL | Standard Deviation 1129.565 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 alpha: Day 180 | -54.416 pg/mL | Standard Deviation 96.391 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-5: Day 180 | 1.732 pg/mL | Standard Deviation 7.974 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-1 RA: Day 180 | -69391.250 pg/mL | Standard Deviation 127840.986 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIP-1 beta: Day 180 | -824.330 pg/mL | Standard Deviation 1063.855 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-17: Day 180 | -25.215 pg/mL | Standard Deviation 36.297 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | MIG: Day 180 | -25881.359 pg/mL | Standard Deviation 110834.744 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Eotaxin: Day180 | -23.358 pg/mL | Standard Deviation 78.999 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-15: Day 180 | -5.039 pg/mL | Standard Deviation 15.169 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | PDGF-BB: Day 180 | -55.547 pg/mL | Standard Deviation 127.111 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Basic FGF: Day 180 | -117.656 pg/mL | Standard Deviation 183.542 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-13: Day 180 | -43.758 pg/mL | Standard Deviation 93.016 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | G-CSF:Day 180 | -112.012 pg/mL | Standard Deviation 9701.76 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-12 P70: Day 180 | -40.912 pg/mL | Standard Deviation 64.739 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IL-4: Day 180 | -1.435 pg/mL | Standard Deviation 3.571 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | GM-CSF: Day 180 | -79.668 pg/mL | Standard Deviation 157.497 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | Il-10: Day 180 | -37.755 pg/mL | Standard Deviation 60.765 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | VEGF: Day 180 | -700.258 pg/mL | Standard Deviation 1154.582 |
| Motavizumab 100 mg/kg | Change From Baseline in Upper Respiratory Tract (Nasal Wash) Cytokine Levels | IFN gamma: Day180 | -2755.333 pg/mL | Standard Deviation 15534.906 |
Secondary
Duration of ICU Stay During RSV Hospitalization
Duration of ICU stay during RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who were admitted to ICU were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motavizumab 30 mg/kg | Duration of ICU Stay During RSV Hospitalization | 7.3 Days | Standard Deviation 4.6 |
| Motavizumab 100 mg/kg | Duration of ICU Stay During RSV Hospitalization | 5.0 Days | Standard Deviation 4 |
Secondary
Duration of Mechanical Ventilation During RSV Hospitalization
Duration of mechanical ventilation during RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received mechanical ventilation during RSV hospitalization were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motavizumab 30 mg/kg | Duration of Mechanical Ventilation During RSV Hospitalization | 7.81 Days | Standard Deviation 0.88 |
| Motavizumab 100 mg/kg | Duration of Mechanical Ventilation During RSV Hospitalization | 4.64 Days | Standard Deviation 2.3 |
Secondary
Duration of RSV Hospitalization
Duration of RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of RSV Hospitalization | 3.55 Days | Standard Deviation 2.43 |
| Motavizumab 30 mg/kg | Duration of RSV Hospitalization | 3.98 Days | Standard Deviation 3.01 |
| Motavizumab 100 mg/kg | Duration of RSV Hospitalization | 4.46 Days | Standard Deviation 4.33 |
Secondary
Duration of Supplemental Oxygen Use During RSV Hospitalization
Duration of supplemental oxygen use during RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants who received supplemental oxygen during RSV hospitalization were analyzed for this outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Duration of Supplemental Oxygen Use During RSV Hospitalization | 3.5 Days | Standard Deviation 1.8 |
| Motavizumab 30 mg/kg | Duration of Supplemental Oxygen Use During RSV Hospitalization | 4.1 Days | Standard Deviation 2.8 |
| Motavizumab 100 mg/kg | Duration of Supplemental Oxygen Use During RSV Hospitalization | 4.4 Days | Standard Deviation 4.1 |
Secondary
Heart Rate During RSV Hospitalization
Heart rate during RSV hospitalization is reported.
Time frame: Days 0, 1, 2, 3, 7, and 30
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heart Rate During RSV Hospitalization | Day 0 | 148.6 Beats per minute | Standard Deviation 17.8 |
| Placebo | Heart Rate During RSV Hospitalization | Day 1 | 146.0 Beats per minute | Standard Deviation 18 |
| Placebo | Heart Rate During RSV Hospitalization | Day 2 | 141.2 Beats per minute | Standard Deviation 11.9 |
| Placebo | Heart Rate During RSV Hospitalization | Day 3 | 138.6 Beats per minute | Standard Deviation 14.8 |
| Placebo | Heart Rate During RSV Hospitalization | Day 7 | 139.6 Beats per minute | Standard Deviation 14.8 |
| Placebo | Heart Rate During RSV Hospitalization | Day 30 | 139.6 Beats per minute | Standard Deviation 13.4 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 30 | 140.3 Beats per minute | Standard Deviation 13.8 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 0 | 155.6 Beats per minute | Standard Deviation 19.5 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 3 | 140.7 Beats per minute | Standard Deviation 14.8 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 7 | 141.4 Beats per minute | Standard Deviation 20.2 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 1 | 145.9 Beats per minute | Standard Deviation 14.6 |
| Motavizumab 30 mg/kg | Heart Rate During RSV Hospitalization | Day 2 | 139.6 Beats per minute | Standard Deviation 15.1 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 1 | 145.9 Beats per minute | Standard Deviation 17.3 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 2 | 136.6 Beats per minute | Standard Deviation 17.3 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 30 | 137.1 Beats per minute | Standard Deviation 13 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 3 | 143.3 Beats per minute | Standard Deviation 17.4 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 0 | 157.6 Beats per minute | Standard Deviation 17 |
| Motavizumab 100 mg/kg | Heart Rate During RSV Hospitalization | Day 7 | 143.5 Beats per minute | Standard Deviation 15.9 |
Secondary
Number of Participants Admitted to the Intensive Care Unit (ICU)
Number of participants admitted to ICU is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Admitted to the Intensive Care Unit (ICU) | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants Admitted to the Intensive Care Unit (ICU) | 3 Participants |
| Motavizumab 100 mg/kg | Number of Participants Admitted to the Intensive Care Unit (ICU) | 3 Participants |
Secondary
Number of Participants on Mechanical Ventilation During RSV Hospitalization
Number of participants on mechanical ventilation during RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants on Mechanical Ventilation During RSV Hospitalization | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants on Mechanical Ventilation During RSV Hospitalization | 2 Participants |
| Motavizumab 100 mg/kg | Number of Participants on Mechanical Ventilation During RSV Hospitalization | 2 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs
Time frame: From the start of study drug (Day 0) through Day 30
Population: Safety population included all the participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypercalcaemia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Thrombocythaemia | 1 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypernatraemia | 1 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypokalaemia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Platelet count increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypoalbuminaemia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Liver function test abnormal | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Blood urea increased | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperkalaemia | 0 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Anaemia | 1 Participants |
| Placebo | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperphosphatasaemia | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Platelet count increased | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypoalbuminaemia | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Blood urea increased | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Liver function test abnormal | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Anaemia | 3 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Thrombocythaemia | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypokalaemia | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypercalcaemia | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperkalaemia | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypernatraemia | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperphosphatasaemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypernatraemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypercalcaemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Liver function test abnormal | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypoalbuminaemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperkalaemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Blood urea increased | 1 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Platelet count increased | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Thrombocythaemia | 1 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hyperphosphatasaemia | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Hypokalaemia | 1 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Clinical Laboratory Abnormalities Reported as TEAEs | Anaemia | 1 Participants |
Secondary
Number of Participants With Detectable Anti-motavizumab Antibodies
Number of participants with detectable anti-motavizumab antibodies are reported. Detection is defined as an anti-motavizumab antibody titer with a dilution value of 1:30 or greater.
Time frame: Days 0, 180, and 360
Population: Evaluable population for anti-drug antibody included all participants who received a full dose of study drug. Participants with adequate anti-motavizumab antibody titer samples at the specified time points were analyzed for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 0 | 1 Participants |
| Placebo | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 180 | 11 Participants |
| Placebo | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 360 | 21 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 0 | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 180 | 10 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Detectable Anti-motavizumab Antibodies | Day 360 | 14 Participants |
Secondary
Number of Participants With Medically-attended Wheezing Episodes
Wheezing episodes are considered medically-attended wheezing episodes if the medical care provider verifies and documents wheezing in the medical record or, in the case of hospitalization, the medical care provider assigns a discharge diagnosis of asthma, bronchiolitis, wheezing, or reactive airway disease. A new wheezing episode is the one that occurs for more than 2 weeks after the diagnosis of the previous episode and the medical opinion is that the wheezing does not represent a persistence of the previous episode. Medically-attended wheezing episodes were calculated and reported in the range of 0 to 9 events.
Time frame: From randomization (Day 0) through Day 360 (approximately 12 months)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 0 event | 2 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 1 event | 19 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 2 events | 9 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 3 events | 1 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 4 events | 2 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 5 events | 2 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 6 events | 2 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 7 events | 0 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 8 events | 0 Participants |
| Placebo | Number of Participants With Medically-attended Wheezing Episodes | 9 events | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 8 events | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 0 event | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 5 events | 3 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 4 events | 4 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 1 event | 20 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 9 events | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 7 events | 0 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 2 events | 6 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 6 events | 1 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 3 events | 4 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 7 events | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 3 events | 4 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 4 events | 3 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 5 events | 2 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 8 events | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 6 events | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 0 event | 2 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 9 events | 0 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 1 event | 18 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Medically-attended Wheezing Episodes | 2 events | 7 Participants |
Secondary
Number of Participants With Supplemental Oxygen Use During RSV Hospitalization
Number of participants with supplemental oxygen use during RSV hospitalization is reported.
Time frame: From Randomization Day (Day 0) to Discharge Day (up to Day 30)
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Participants with hospitalization information available were analyzed for this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Supplemental Oxygen Use During RSV Hospitalization | 24 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Supplemental Oxygen Use During RSV Hospitalization | 30 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Supplemental Oxygen Use During RSV Hospitalization | 29 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Time frame: From the start of study drug (Day 0) through Day 90
Population: Safety population included all the participants who received any dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAEs | 33 Participants |
| Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAEs | 6 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAEs | 28 Participants |
| Motavizumab 30 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAEs | 6 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TEAEs | 32 Participants |
| Motavizumab 100 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Any TESAEs | 7 Participants |
Secondary
Oxygen Saturation Level During RSV Hospitalization
Oxygen saturation level during RSV hospitalization is reported.
Time frame: Days 0, 1, 2, 3, 7, and 30
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 0 | 96.8 Percentage of oxygen saturation | Standard Deviation 2.5 |
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 1 | 97.3 Percentage of oxygen saturation | Standard Deviation 2.3 |
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 2 | 96.9 Percentage of oxygen saturation | Standard Deviation 2.4 |
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 3 | 97.7 Percentage of oxygen saturation | Standard Deviation 1.8 |
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 7 | 97.6 Percentage of oxygen saturation | Standard Deviation 1.9 |
| Placebo | Oxygen Saturation Level During RSV Hospitalization | Day 30 | 97.9 Percentage of oxygen saturation | Standard Deviation 1.7 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 30 | 98.1 Percentage of oxygen saturation | Standard Deviation 1.8 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 0 | 97.5 Percentage of oxygen saturation | Standard Deviation 1.9 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 3 | 97.6 Percentage of oxygen saturation | Standard Deviation 1.7 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 7 | 97.8 Percentage of oxygen saturation | Standard Deviation 1.4 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 1 | 98.1 Percentage of oxygen saturation | Standard Deviation 1.6 |
| Motavizumab 30 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 2 | 97.3 Percentage of oxygen saturation | Standard Deviation 2.1 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 1 | 97.2 Percentage of oxygen saturation | Standard Deviation 2.1 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 2 | 97.5 Percentage of oxygen saturation | Standard Deviation 2 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 30 | 98.5 Percentage of oxygen saturation | Standard Deviation 1.3 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 3 | 97.4 Percentage of oxygen saturation | Standard Deviation 2.3 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 0 | 97.1 Percentage of oxygen saturation | Standard Deviation 3.1 |
| Motavizumab 100 mg/kg | Oxygen Saturation Level During RSV Hospitalization | Day 7 | 97.6 Percentage of oxygen saturation | Standard Deviation 2.3 |
Secondary
Respiratory Assessment Change Score (RACS) Derived From Baseline
The RACS assesses changes in wheezing and retractions as measured by respiratory distress assessment instrument (RDAI) score and changes in respiratory rate. A RDAI score is a measure of the degree of severity of wheezing and retractions, with score range from 0 to 17; higher scores indicate more severe disease. Respiratory rate is summarized by raw scores and standardized change score. A change in respiratory rate of less than or equal to (\<=) 5% from baseline is counted as a change of 0 units and a change in respiratory rate is assigned 1 point per each 10% change in the respiratory rate. The RACS is calculated as arithmetic sum of RDAI score change and of standardized respiratory rate change (for example, a child showing improvement who had a RDAI of -5 and a respiratory rate change of -2 would have a RACS score of -7). The RACS assessment does not have a minimum and/or maximum scale range. A decrease in RACS represents improvement, whereas an increase signifies deterioration.
Time frame: Baseline (Day 0), Days 1, 2, 3, 7, and 30
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 7 | -5.70 Units on a score | Standard Deviation 5.4 |
| Placebo | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 3 | -4.29 Units on a score | Standard Deviation 5.45 |
| Placebo | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 1 | -1.81 Units on a score | Standard Deviation 5.05 |
| Placebo | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 2 | -2.14 Units on a score | Standard Deviation 5.2 |
| Placebo | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 30 | -6.00 Units on a score | Standard Deviation 5.51 |
| Motavizumab 30 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 3 | -5.49 Units on a score | Standard Deviation 4.53 |
| Motavizumab 30 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 1 | -1.36 Units on a score | Standard Deviation 4.47 |
| Motavizumab 30 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 2 | -3.51 Units on a score | Standard Deviation 4.72 |
| Motavizumab 30 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 7 | -6.94 Units on a score | Standard Deviation 4.89 |
| Motavizumab 30 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 30 | -7.14 Units on a score | Standard Deviation 4.88 |
| Motavizumab 100 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 30 | -7.79 Units on a score | Standard Deviation 4.01 |
| Motavizumab 100 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 7 | -6.18 Units on a score | Standard Deviation 5.23 |
| Motavizumab 100 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 1 | -2.11 Units on a score | Standard Deviation 4.58 |
| Motavizumab 100 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 3 | -5.41 Units on a score | Standard Deviation 5.11 |
| Motavizumab 100 mg/kg | Respiratory Assessment Change Score (RACS) Derived From Baseline | Day 2 | -3.61 Units on a score | Standard Deviation 5.02 |
Secondary
Respiratory Rate During RSV Hospitalization
Respiratory rate during RSV hospitalization is reported.
Time frame: Days 0, 1, 2, 3, 7, and 30
Population: RSV evaluable population included all participants who were RSV positive at Study Day 0 by real-time RT-PCR. Here, 'Number Analyzed' denotes those participants who were evaluable at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Respiratory Rate During RSV Hospitalization | Day 0 | 46.86 Breaths per minute | Standard Deviation 10.2 |
| Placebo | Respiratory Rate During RSV Hospitalization | Day 1 | 44.35 Breaths per minute | Standard Deviation 11.88 |
| Placebo | Respiratory Rate During RSV Hospitalization | Day 2 | 46.46 Breaths per minute | Standard Deviation 9.05 |
| Placebo | Respiratory Rate During RSV Hospitalization | Day 3 | 43.03 Breaths per minute | Standard Deviation 9.28 |
| Placebo | Respiratory Rate During RSV Hospitalization | Day 7 | 41.76 Breaths per minute | Standard Deviation 9.06 |
| Placebo | Respiratory Rate During RSV Hospitalization | Day 30 | 38.45 Breaths per minute | Standard Deviation 6.73 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 30 | 41.11 Breaths per minute | Standard Deviation 12.81 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 0 | 49.28 Breaths per minute | Standard Deviation 8.93 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 3 | 40.54 Breaths per minute | Standard Deviation 8.54 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 7 | 40.14 Breaths per minute | Standard Deviation 9.14 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 1 | 48.67 Breaths per minute | Standard Deviation 12.41 |
| Motavizumab 30 mg/kg | Respiratory Rate During RSV Hospitalization | Day 2 | 41.89 Breaths per minute | Standard Deviation 10.76 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 1 | 48.00 Breaths per minute | Standard Deviation 14.13 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 2 | 44.11 Breaths per minute | Standard Deviation 11.77 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 30 | 38.45 Breaths per minute | Standard Deviation 6.53 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 3 | 43.68 Breaths per minute | Standard Deviation 10.81 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 0 | 51.78 Breaths per minute | Standard Deviation 11.28 |
| Motavizumab 100 mg/kg | Respiratory Rate During RSV Hospitalization | Day 7 | 43.64 Breaths per minute | Standard Deviation 11.06 |
Secondary
Serum Concentration of Motavizumab
Motavizumab concentration in serum is reported.
Time frame: Days 1, 7, 90, 180, and 360
Population: Evaluable population for PK included all participants who received a full dose of study drug. Participants with adequate motavizumab concentration in serum at the specified time points were analyzed for this outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Concentration of Motavizumab | Day 7 | 192.87 mcg/mL | Standard Deviation 57.07 |
| Placebo | Serum Concentration of Motavizumab | Day 180 | 0.64 mcg/mL | Standard Deviation 1.41 |
| Placebo | Serum Concentration of Motavizumab | Day 90 | 11.39 mcg/mL | Standard Deviation 9.35 |
| Placebo | Serum Concentration of Motavizumab | Day 360 | 0.04 mcg/mL | Standard Deviation 0.26 |
| Placebo | Serum Concentration of Motavizumab | Day 1 | 298.73 mcg/mL | Standard Deviation 88.99 |
| Motavizumab 30 mg/kg | Serum Concentration of Motavizumab | Day 360 | 0 mcg/mL | Standard Deviation 0 |
| Motavizumab 30 mg/kg | Serum Concentration of Motavizumab | Day 1 | 863.05 mcg/mL | Standard Deviation 240.28 |
| Motavizumab 30 mg/kg | Serum Concentration of Motavizumab | Day 7 | 640.36 mcg/mL | Standard Deviation 95.69 |
| Motavizumab 30 mg/kg | Serum Concentration of Motavizumab | Day 90 | 30.81 mcg/mL | Standard Deviation 23.63 |
| Motavizumab 30 mg/kg | Serum Concentration of Motavizumab | Day 180 | 2.45 mcg/mL | Standard Deviation 3.54 |